Heart Patients Seek Guidance on Stents, Statins

3/30/2007

FRIDAY, March 30 (HealthDay News) -- A number of controversial findings presented during the American College of Cardiology meeting this week has probably left many heart patients scratching their heads over which treatment is best for their particular cardiovascular condition.

Experts note the answer has never been easy, and what works for one heart patient might not work for another.

"I think that we sometimes try and make things too simple, in the media and in the scientific community," said Dr. Stephen Siegel, a cardiologist at the New York University Medical Center in New York City. "The goal is to translate that information from evidence-based medicine, to take care of each patient."

One study overturned the long-held notion that surgical techniques such as angioplasty and stenting were better than drug therapy at treating stable heart disease. Other studies questioned the usefulness and safety of expensive, drug-coated stents. And other trials trumpeted the expanding benefits of statins, raising the question of who shouldn't be taking these drugs.

Take the angioplasty-vs.-drug therapy debate. The study of almost 2,300 patients found no differences in death, nonfatal heart attacks, strokes or hospitalization between patients with "stable" heart disease treated with medication alone vs. those who got drugs plus angioplasty and stenting.

While many cardiologists welcomed the findings, stent manufacturers and some interventional cardiologists (doctors specializing in procedures such as angioplasty) said the study was biased in favor of drug therapy. The trial was overseen by U.S. and Canadian health agencies but did receive funding from the pharmaceutical industry.

However, Dr. Raymond Gibbons, president of the American Heart Association, said the study simply "challenges an assumption that has often been present in both patients and doctors, which was that doing an angioplasty and stenting a blockage would reduce the chance of death and heart attack," he said. "The trial clearly shows that that is not the case."

Gibbons, who is also professor of medicine at the Mayo Clinic in Rochester, Minn., stressed that the trial had to pass muster not only with the ACC but with the tough peer-review board at the New England Journal of Medicine, which published the results this week.

"Mayo, where I work, was a center in this trial," he added. "If we had had any concerns about the study's design, we would not have participated."

Gibbons stressed that the findings only apply to patients with chronic but stable heart disease. These patients may experience intermittent chest pain (angina) but have no history of heart attack.

"We need to recognize that the study does not apply to acute heart attack [patients]," he said. The study also does not apply to patients with stable heart disease whose chest pain has not responded to medicines, Gibbons added. Both of those groups are very appropriate candidates for invasive procedures such as angioplasty, he said.

According to Siegel, in too many cases, patients with stable heart disease are routinely sent off for an angiogram. And once doctors notice an obstruction -- any obstruction -- their temptation is to surgically remove it.

"There's clearly a gut reaction when you see a closed artery -- that it's better to have it opened," said Siegel, who is also clinical assistant professor at New York University School of Medicine. "But the trouble with the whole concept of 'opening everything' is that it does nothing for the underlying disease."

Angioplasty and stents both come with risk, he said, and the new study shows that, in many cases, it may be best to resist that urge to perform surgery and see if medicines can do the trick on their own.

Another expert agreed. "If you are having really horrible chest pain with exertion, it may be appropriate to have a stent, but too often, they are being done with just the promise of preventing a heart attack, and they don't do that," said Dr. Arthur Agatston, an associate professor of medicine at the University of Miami School of Medicine. He said he rarely treats chronic heart disease patients with stents, preferring medication and lifestyle change instead.

Drugs such as aspirin, statins, beta blockers and ACE inhibitors ease the inflammation and cholesterol build-up that causes cardiovascular disease to begin with, the experts said.

"The key to remember here is that every patient needs medical therapy," Gibbons said, "because angioplasty only treats the area of the artery with the severe blockage. If people find a physician who does not seem to believe in optimal medical therapy, then they should find another physician."

Other studies at the meeting highlighted the potential pitfalls of drug-coated stents, which can cost upwards of $2,000 each. Medications embedded in the devices keep artery re-closure at bay, but the use of these devices has also been linked to the occasional development of large clots. For that reason, patients are advised to take blood-thinners such as aspirin and clopidogrel (Plavix) for at least one year after stent placement.

However, two studies found that some stented patients don't respond to Plavix (raising their clot risk), and about 30 percent of patients fail to take the medications as prescribed.

So, are drug-coated stents appropriate for everyone in serious danger of heart attack or stroke? Certainly not, the experts said.

Because patients must take blood-thinning aspirin and Plavix, "if the patient has increased bleeding risks, then drug-eluting stents are not for them," Gibbons said. "For patients needing non-cardiac surgery within the next 12 months, drug-eluting stents are not a good option. And if patient's resources are such that they are unlikely to be able to afford clopidogrel for the next year, drug-eluting stents are not for them."

Otherwise, the advantage of a drug-coated stent is assessed by doctors on a case-by-case basis, Gibbons said. "The advantage often depends on the size of the blood vessel and individual patient characteristics," he explained.

Finally, there was more good news at the ACC meeting on the role of LDL ("bad") cholesterol-lowering statins. Use of one such drug, Crestor, helped keep plaque from settling in arteries, a study found. Another trial found that the prompt use of Lipitor in the emergency room boosted the long-term survival of patients after heart attack.

Statins typically come with very few side effects, raising the question of whether everyone over a certain age might someday take them.

Like many heart doctors, Siegel is a big supporter of statins, which he called one of the "foundations" of current therapy aimed at lowering heart risks. But he said he doesn't recommend them across the board to patients.

"Let's say you have an LDL cholesterol of 108 -- a little bit over the 100 'desirable' range but less than [the more dangerous] 130," he said. "Now, if you have a family history where your grandparents are alive at 98, and nobody's ever had heart disease, I wouldn't even think about prescribing it," Siegel said. "On the other hand, if your father dropped dead at 42 of a heart attack, I don't care what your cholesterol is, I would put you on a statin."

The bottom line, according to Siegel, is that big clinical trials are great, but every patient is unique.

"There's not a 'large group of patients' sitting across from my desk, or on my exam table," he said. "It's an individual."

SOURCES: Raymond Gibbons, M.D., president, American Heart Association, and professor, medicine, Mayo Clinic College of Medicine, Rochester, Minn.; Stephen Siegel, M.D., cardiologist, New York University Medical Center, and clinical assistant professor, New York University School of Medicine, New York City; Arthur Agatston, associate professor, medicine, University of Miami School of Medicine; March 23-27, 2007, presentations, American College of Cardiology annual meeting, New Orleans